“Our study further evaluates the percutaneous application of the IlluminOss System, which is a light-curable photodynamic bone stabilization device developed by IlluminOss Medical, Inc. as a safe and biocompatible treatment for fracture stabilization and repair in load-bearing bones, such as the long bones of the leg,” said co-investigator Brett G. Zani, Ph.D., director of Applied Sciences, CBSET, in the March 23, 2017 news release.

“Local biocompatibility evaluations comparing the IlluminOss System to standard K-wire implants showed no significant long-term local tissue reactions associated with either implant, and good systemic biocompatibility of the IlluminOss System over the course of a year,” added co-investigator and CBSET scientist Amanda L. McSweeney.

According to the news release, “The implant begins as a liquid monomer that is completely contained within a Dacron or PET [polyethylene terephthalate] balloon. Once inside a patient’s bone, it conforms to the geometry of that patient’s intramedullary canal, whereas traditional rigid intramedullary rods have only small discrete contact points. Now, international surgeons have the option to use the IlluminOss product alone or in conjunction with traditional hardware and screws for multiple types of fractures.”

Robert Rabiner, founder and chief technical officer of IlluminOss Medical, told OTW, “The perceived product utility and the multiple clinical applications that we saw in the lab were similarly recognized by our early surgeon-users. The early adopters of IlluminOss were able to quickly grasp not only the utility of the product, but also to be able to implement it directly into their clinical practice and become the standard of care for many of them.”

“Not only were we rewarded with sustained utilization of the product, but we were able to become a valuable tool in their surgical armamentarium in treating fractures of highly compromised bone. In fact 34% of the patients initially treated were ‘redo’ patients where conventional products had failed.”

“Based upon the tremendous and ongoing commercial success that we have obtained with the product in Europe and the recent completion of our U.S. clinical trial, I would hope that a year from now we will have achieved approval to initiate commercialization in the U.S. and to bring this incredibly valuable product to the U.S. market.”

The IluminOss System is approved for sale in Europe and for investigational use in the U.S.

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IlluminOss Receives Patent Office OK

Biloine W. Young • Tue, April 15th, 2014

The U.S. Patent and Trademark Office has issued a Notice of Allowance to IlluminOss Medical Inc. for the company’s Photodynamic Bone Stabilization System (PBSS). The IlluminOss devices are limited by federal law to Investigational Use and are not approved for sale in the USA.

According to the company’s description, the minimally invasive PBSS stabilizes bone fractures or prevents impending fractures through its percutaneous, patient customized fracture fixation system. Using PBSS, clinicians insert an angioplasty-like balloon into the intramedullary canal across the fracture site, which is then filled with a liquid monomer. Once the positioning of the implant is verified, light is delivered through a proprietary fiber to cure the monomer for rapid stabilization of the bone. This results in a customized fit to each patient’s specific anatomy providing rotational and torsional stability to the fracture. PBSS can be implanted for stand-alone primary fixation or in combination with screws or plates.

“This strong and growing IP portfolio demonstrates that we are continuing to advance our innovative fracture fixation technologies as we expand our commercial efforts in Europe and work towards gaining regulatory approval in the United States, ” said Robert Rabiner, founder and chief technology officer of IlluminOss. “With the addition of these three new patents, we can confidently say that our IP portfolio covers the whole body.”

Dirk Kuyper, president and CEO of IlluminOss, said, “In addition to the robustness of our patent estate, IluminOss is gathering compelling clinical evidence that shows how our patient-customized approach to fracture repair has the potential to improve clinical outcomes.”

IlluminOss was founded in 2007 and is headquartered in East Providence, Rhode Island. The company currently markets its products under a CE Mark in Austria, Germany, Israel, Italy, the Netherlands, Spain, Switzerland and Turkey.

IlluminOss : Promising Data on LightFix

Elizabeth Hofheinz, M.P.H., M.Ed. • Thu, November 10th, 2016

Richard Terek, M.D. has just presented preliminary data on IlluminOss Medical’s LightFix trial at the recent Musculoskeletal Tumor Society (MSTS) Meeting in Detroit. According to the company, the multicenter study looks at “the IlluminOss System for the treatment of impending and actual pathological fractures in the humerus from metastatic bone disease. Preliminary results from the U.S. trial measured pain and functional improvement, as well as evaluated safety and performance.”

Patients were treated at Rhode Island Hospital by Dr. Terek, an orthopedic surgeon and musculoskeletal oncologist who specializes in reconstructive surgery and musculoskeletal oncology, and professor in the department of orthopedic surgery at The Warren Alpert Medical School of Brown University.

“The investigators found that the technical nature and attributes of the product were viewed to be easier and faster to use, with no limitations to the use of adjunctive hardware, ” said Dr. Terek in the November 1, 2016 news release.

“The preliminary results of the LightFix trial have been extremely positive in that the investigators found that the device was less invasive than many standard orthopedic implants. The early data suggests that the patients achieved a decrease in pain and an increase in return to function through the use of the IlluminOss implant, ” said Dr. Terek. “We are encouraged with the results of the IlluminOss System and look forward to its availability in the USA. It will offer the U.S. market a new and much-needed alternative for the treatment of patients with metastatic bone disease and other complex fractures.”

“This first presentation of our clinical data is consistent with the positive results we have seen in Europe and is further substantiation of the merits of our platform’s capabilities and how they may benefit the orthopedic community, ” said IlluminOss CEO Manny Avila. “We look forward to the presentation of the completed LightFix trial results and the opportunity to provide the product to a much broader patient base.”

Dr. Terek told OTW, “What I found most intriguing was the willingness of patients to try a new product and of orthopedic surgeons to participate in a trial that approaches pathological fracture repair in a way that is very different from existing traditional methods.

IlluminOss: Conditional FDA Approval for Bone Stabilization System

Elizabeth Hofheinz, M.P.H., M.Ed. • Wed, November 26th, 2014

IlluminOss Medical, Inc. is pleased to report that it has received a conditional “green light” from the FDA to conduct a clinical trial for the treatments of impending and pathologic fractures in the humerus due to metastatic carcinoma.

According to the November 18, 2014 news release, IlluminOss’ Photodynamic Bone Stabilization System (PBSS) is the world’s first and only system of its kind and offers significant advantages for the treatment of complex fractures. “Benefits observed from the use of the product in patients include smaller incisions, shorter procedure times, and more rapid post-procedure patient mobility with reduced hospital stays and lower complication rates.”

“The minimally invasive procedure incorporates the use of a thin walled PET [pericardial effusion with tamponade] balloon that is infused with a liquid monomer and inserted into the intramedullary canal of the bone conforming to the shape of the patient's specific bone. The device forms as an implant once the surgeon activates the visible light delivered within the PET balloon. Once cured, the implant provides longitudinal strength and rotational stability over the length of the implant.”

Dr. Martin Malawer, director of the Orthopedic Surgical Oncology and Professor of Orthopedic Surgery at George Washington University Hospital and Professor (Clinical Scholar) of Orthopedic Surgery at Georgetown University, will lead the first U.S. trial of PBSS.

“From what I have seen to date, IlluminOss’ Photodynamic Bone Stabilization System could prove to be a true disruptive technology in the treatment of pathological and non-pathological fractures by orthopedic surgeons, ” said Dr. Malawer in the November 18, 2014 news release. “This technology will potentially reduce surgery time and morbidity rates, as well as lessen complications and improve patient outcomes.”

“We have been exceedingly pleased with the results that surgeons internationally have achieved using our Photodynamic Bone Stabilization System and we are confident that we will see similar benefits for patient outcomes in the U.S. clinical trials, ” said Robert Rabiner, president and founder of IlluminOss Medical, in the news release. “Obtaining this FDA approval has been the vital first step towards ultimately applying our technology to the treatment of fractures in the U.S. and we look forward to serving this critical market.”

IlluminOss Enrolls First Patient in Light Fix Trial

Elizabeth Hofheinz, M.P.H., M.Ed. • Thu, March 5th, 2015

IlluminOss Medical has announced that the first of 45 patients has been enrolled in its EU Light Fix trial. The trial is for the treatment of impending and pathologic fractures in the humerus due to metastatic carcinoma. Professor Reinhard Windhager, M.D. of the University Clinic of Vienna Orthopaedic Department, is leading these efforts. Dr. Windhager heads the Department of Orthopaedic Surgery at Vienna General Hospital (AKH). The trial will involve 10 centers in Austria, Germany and the Netherlands; the first patient enrolled is a female with metastatic cancer of the left humerus.

The IlluminOss System utilizes a light-curable polymer, contained within an expandable balloon catheter, to achieve bone stabilization. The simple, percutaneous surgical approach enables surgeons to create a patient-conforming implant. In many cases it allows the patient to get back to daily activities more quickly without the hindrance of a hard cast. Benefits observed from the use of the product in patients include smaller incisions, shorter procedure times, and more rapid post-procedure patient mobility with reduced hospital stays and lower complication rates. The small diameter of the flexible catheter gives the surgeon greater freedom of surgical approach. Once cured, the implant provides longitudinal strength and rotational stability over the length of the implant.

“The IlluminOss System will potentially allow orthopedic surgeons to approach impending and actual fractures resulting from metastatic malignancy in a groundbreaking way that will benefit both the surgeon and the patient, ” said Professor Windhager in the March 3, 2015 news release. “I am pleased to lead the first Light Fix trial in the EU and hope our efforts will help validate an approach to orthopedic surgery that can provide treatment options for patients that previously had little or no recourse and also potentially lessen complications and improve outcomes.”

“We are honored that Professor Windhager and Vienna General Hospital have chosen to collaborate with IlluminOss Medical on this important trial for the repair and stabilization of impending and pathologic fractures in the humerus due to metastatic carcinoma, ” said Robert Rabiner, president of IlluminOss Medical. “The University Clinic of Vienna Orthopaedic Department has a long tradition of providing the highest standards of patient care, and we believe its practices influence orthopedic treatment approaches throughout Austria and the surrounding European region.

IlluminOss Medical: Two MORE Patents!

Elizabeth Hofheinz, M.P.H., M.Ed. • Tue, December 16th, 2014

Twenty-five…that is the grand total number of U.S. patents owned by IlluminOss Medical, Inc. as of December 9, 2014. The company has just announced that it has been issued two new patents related to its internal bone fixation system. The patents include “kits for repairing a weakened or fractured bone, as well as internal bone fixation devices and systems for internal fixation of a fractured bone, and methods for internal fixation of a fractured bone.”

According to the December 10, 2014 news release, “The proprietary IlluminOss System incorporates the use of a thin-walled PET balloon that is infused with a liquid monomer and inserted into the intramedullary canal of the bone conforming to the shape of the patient’s specific bone. The device forms as an implant once the surgeon activates the visible light delivered within the PET balloon. Once cured, the implant provides longitudinal strength and rotational stability over the length of the implant.”

“2014 has been a pivotal year for IlluminOss, as we have continued to see successful results from the use of our orthopedic implant system in international markets and now the enrollment process is underway for our first U.S. clinical trial, ” said company President Robert Rabiner.

The company indicates that with its minimally invasive procedure patients are often back to daily activities more quickly than if they had been burdened with a hard cast. IlluminOss says that thus far, patients have experienced shorter procedure times, smaller incisions, and faster postop mobility. In addition, inpatient times and lower complication rates have also been reported.

Rabiner told OTW, “Our focus is to continue to make strides towards making IlluminOss’ approach to fracture repair a game changer in how orthopedic surgery will be performed worldwide. Over the next 12 months we will be collecting and analyzing data from our first U.S. clinical trial—which we expect will replicate the successful findings that have been achieved in Europe where the IlluminOss System has been effectively used in 700+ patient procedures, as well as two additional trials for new and increased clinical indications in Europe.”